MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RADIAL HEAD PROSTHESIS; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Device Slipped (1584)

Patient Problems Failure of Implant (1924); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 20mm radial head/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is an attorney.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2020, the patient underwent left radial head implant removal surgery due to the loosening of the radial prosthesis which was due to mechanical abrasion rather than infection.On or about (b)(6) 2014, the patient had revision surgery, in which previously implanted synthes radial head (22mm) and stem (8mm) were removed and patient was implanted with a depuy synthes radial head (20mm) and stem (7mm).However, by mid-2019, the patient was suffering increased pain, as well as clicking and popping noises in her left arm.She eventually got to the point where she was having pain every day, the pain was waking her up at night, and the pain was affecting her daily activities.On (b)(6) 2019, an x-ray demonstrated radiolucency involving the entire bone component interface suggesting loosening.On or about (b)(6) 2020, radiology images noted a wide radiolucent band around the intramedullary component of the device that spans 4 to 5mm.On (b)(6) 2020, the patient underwent left radial head implant removal surgery due to the loosening of the radial prosthesis which was due to mechanical abrasion rather than infection.Dr.(b)(6) packed the radial shaft with antibiotics in case of infection.However, the culture results all came back negative, indicating there was no infection.On or about (b)(6) 2020, it was noted in the mri that there was a concern for a central band interosseous membrane injury.The doctor noted she had good elbow flexion and extension, but painful clicking with pronation and supination.On or about (b)(6) 2020, the patient underwent reconstructive surgery to help with the proximal radius and ulnar convergence, audible clicking and forearm pain.The surgeon was unable to implant another radial head prosthesis to restore her forearm function because the synthes radial stem caused so much damage to her radius bone.Instead, the surgeon performed a left proximal radial stabilization using allograft anterior tibialis tendon secured to both radial shaft and the lateral column of the humerus and capitellum.Post-surgery, the patient underwent a few outpatient therapy sessions but limited her therapy to ensure that the graft would heal properly.This complaint reports the removal surgery performed on (b)(6) 2020; however related complaint (b)(4) captures the first revision surgery performed on (b)(6) 2014.This report is for one unknown 20mm radial head.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: photo investigation: the device was not returned.A photo-investigation was performed on the images.The image indicated that there was a significant amount of bone degradation (osteolysis) around the implant, leading to a loose implant condition.No apparent device malfunction, damage, or defect was noted in the images.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint of a reported loose implant condition was confirmed during investigation.No manufacturing issues were noted during investigation.There are known issues with the radial head implants; the issue was attributed to design control process issues, which have been addressed.Relevant actions have been taken to address the issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no additional corrective and/or preventive action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - RADIAL HEAD PROSTHESIS
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11353478
• MDR Text Key: 239697333
• Report Number: 2939274-2021-00980
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 62